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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

NCT ID: NCT00956436

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-04-30

Brief Summary

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This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Keywords

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Liver Cancer Hepatocellular Carcinoma Sorafenib HCC BIIB022 Open-Label IGF-1R Nexavar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib Monotherapy

Sorafenib Monotherapy

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

Standard dosing of Sorafenib

Sorafenib with BIIB022

Sorafenib with BIIB022

Group Type EXPERIMENTAL

BIIB022

Intervention Type DRUG

IV Q3W

Interventions

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BIIB022

IV Q3W

Intervention Type DRUG

Sorafenib

Standard dosing of Sorafenib

Intervention Type DRUG

Other Intervention Names

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IGF-1R Liver Cancer Hepatocellular Carcinoma Monoclonal Antibody Sorafenib HCC Nexavar HCC Monoclonal Antibody Hepatocellular Carcinoma Liver Cancer BIIB022 IGF-1R Nexavar

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
* Child-Pugh score A5 or A6.
* ECOG Performance Status of ≤2.

Exclusion Criteria

* Known central nervous system or brain metastases.
* Prior anti-IGF-1R therapy.
* Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
* Concurrent anticancer therapy.
* History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
* Acute hepatitis
* Fibrolamellar HCC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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PRA, Int'l

Locations

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Resesarch Site

Denver, Colorado, United States

Site Status

Resesarch Site

Ocoee, Florida, United States

Site Status

Resesarch Site

Indianapolis, Indiana, United States

Site Status

Resesarch Site

Boston, Massachusetts, United States

Site Status

Resesarch Site

New York, New York, United States

Site Status

Resesarch Site

Norfolk, Virginia, United States

Site Status

Resesarch Site

Singapore, , Singapore

Site Status

Resesarch Site

Tainan City, , Taiwan

Site Status

Resesarch Site

Taipei, , Taiwan

Site Status

Resesarch Site

Taoyuan District, , Taiwan

Site Status

Resesarch Site

Edgbaston, Birmingham, United Kingdom

Site Status

Countries

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United States Singapore Taiwan United Kingdom

Other Identifiers

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212HC201

Identifier Type: -

Identifier Source: org_study_id